A Look at the Risks of Pelvic Mesh Implants and the FDA’s Approval Process

This week, in addition to the usual suspects—Craig Ashton, Edward Schade, and Timothy Hodson—the All Things Legal team was joined by a special guest, John Miller. John, who recently joined Ashton & Price as an associate attorney, came on the show to share his expertise about pelvic mesh and the thousands of lawsuits spawned by the serious health problems resulting from the medical devices.

The FDA’s Recent Reclassification of Pelvic Mesh Devices

Craig Ashton led off the discussion by summarizing recent events: “The Food and Drug Administration has set some new rules for what has been deemed an injury-prone medical device: pelvic mesh [also known as ‘transvaginal mesh’]. Mesh implants are used to repair pelvic collapse in women, and will face new federal scrutiny. This is not to be confused with the mesh for hernias or urinary incontinence. It’s a different use of it. Plastic mesh is often used to strengthen the pelvic wall in cases of so-called ‘pelvic organ prolapse,’ in which the bladder or reproductive organs slip out of place, causing pain. The mesh is inserted through the vagina using a small surgical incision. The mesh products were introduced for pelvic repair, but there have become many complications…

“The primary defendants in these cases are Johnson & Johnson, Boston Scientific, and Endo International. Endo International saw the writing on the wall and put forward $830 million to settle more than 200,000 personal injury cases. Now, basically, the FDA says, ‘Look, we’ve looked at this, and this is now a high risk medical device, and it’s subject to additional regulatory requirements.’ Before, it was considered a moderate risk device…”

How Pelvic Mesh Was Originally Approved by the FDA

Craig Ashton then turned to fellow lawyer John Miller—who has worked as a lawyer for more than 25 years and has handled many legal cases involving pelvic mesh devices—to go into more detail about the controversy surrounding the medical use of pelvic mesh:

“The pelvic mesh products, which came on the market in the 1990s, initially underwent what’s called a 510(k) process, which is a streamlined process for FDA approval, and that applies to [manufacturers] that have some type of product that [is] substantially equivalent on the market. And that is a mechanism by which a product, no matter how potentially dangerous, can be approved within a very short period of time with very few tests, very few regulations.”

[A note: This means that if a manufacturer has developed a product for one use, and then subsequently finds that the product can be modified to work for other things, they can use the 510(k) process to fast-track approval of the modified product. In this case, since the late 1980s, surgical mesh devices made by a number of manufacturers have been used for hernia repairs. These mesh devices were then adapted to be used for pelvic repair, and approved through the FDA’s fast-track process.]

“On the other side of that coin, most FDA products do not go through that streamlined procedure, but they require FDA premarket approval, which is a far more strenuous mechanism by which products are tested, there has to be studies, and the FDA has to approve those products. The vast majority of these pelvic mesh manufacturers that Mr. Ashton mentioned… chose the streamlined process. And it’s kind of interesting in the United States, whether it’s a drug product, or a mechanical product, or a… medical product, if it undergoes this streamlined [process], you have the ability as an injured plaintiff to sue them. If it undergoes the more stringent FDA premarket approval, that premarket approval preempts all state law, and you cannot sue that manufacturer. So, these mesh products manufactured by Ethicon, and C. R. Bard, and Boston Scientific, and Johnson & Johnson, all underwent the streamlined [process], making those manufacturers amenable to lawsuit.”

The Health Consequences of Pelvic Mesh Devices

Miller went on to describe the serious health complications that have afflicted many women whose pelvic organ prolapses were repaired using transvaginal mesh: “Like Craig mentioned, these products are installed in women, typically after pregnancy if they have some pelvic organ prolapse, meaning that some of the organs in the abdomen have fallen down by virtue of the stretching involved in pregnancy, and either plastic wire or other [types of] mesh products are inserted. The problem with the products is, number one, it has been determined they don’t work, and number two, they can cause extreme complications: bleeding, pain, incontinence, the inability to have sexual intercourse, cramping, bloating, etc. And for the most part, these products need to be removed, which is an extremely invasive surgery. Oftentimes if it’s the traditional mesh products, many of the organs that the products are designed to support actually grow through the product… So they literally have to go in with clippers or wire cutters and cut out the tissue from amongst the product itself, since they’re interchanged with each other, and that can lead to significant other issues, including nerve damage and permanent nerve damage. And it’s not a good thing to have women be numb in that particular area of their body for the rest of their lives.”

Legal Recourses for Women Injured by Pelvic Mesh Devices

John Miller then explained the legal options available to victims of injuries caused by pelvic mesh devices: “So, there’s a two year statute of limitations on this, meaning that in typical personal injury, you have two years from the date you’re injured [to file a lawsuit]. In these situations a lot of the women who’ve had these products installed in their body do not understand or do not recognize that the symptoms they’re having are related to that particular product. So there’s something called ‘delayed discovery,’ where you can still file a lawsuit within two years of the date you knew or suspected that the product is causing these various and numerous symptoms. So, even though you may have had your product installed years ago, if your symptoms are just arising, or you’re just learning about this on this show, or from TV advertisements from national lawyers, you still have time potentially to file a claim.”

As some of the current high-profile cases involving the use of transvaginal mesh wind their way through state and federal courts, All Things Legal will be sure to revisit this topic in future episodes. In the meantime, if you are suffering from health complications related to the use of transvaginal mesh, or believe that may be the case, Ashton & Price and can help. Call us at 916-786-7787, or email us through our site’s contact page, and we will quickly schedule you for a risk-free, no-cost consultation to review the merits of your case.

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